“EGS continues to lay the foundation for success having achieved a number of important commercial milestones in recent months,” said Mike Carusi, General Partner, Advanced Technology Ventures. “The company is very well positioned to continue the acceleration of its growth going forward. ATV and our fellow EGS co-investors are very excited about the company’s prospects to become the leading long-term solution in the treatment of GERD.”

EGS plans to supplement existing cash balances with these new proceeds to continue its commercial expansion of the TIF® procedure in support of its growing physician customer base, while continuing to invest in sustaining engineering to optimize gross margin.

“This round of funding will enable EGS to continue to expand commercial operations and provide the millions of patients suffering from GERD access to the TIF procedure,” said Skip Baldino, President and CEO of EndoGastric Solutions. “Recent publications demonstrating both durability and efficacy along with the FDA’s expanded labeling to include TIF procedures performed concomitantly with a hiatal hernia repair and the release of the third generation EsophyX Z+ device have positioned the company for rapid growth. In addition, recent reclassification of outpatient payments now more accurately align with the true cost of the TIF procedure and will further the clinical adoption of this important treatment option.”

About GERD

Gastroesophageal reflux disease (GERD) is a chronic condition in which the gastroesophageal valve (GEV) allows gastric contents to reflux (wash backwards) into the esophagus, causing heartburn and possible injury to the esophageal lining. In the United States (U.S.), GERD is the most common gastrointestinal-related diagnosis physicians make during clinical visits. Pain and discomfort from acid reflux impact more than 80 million Americans at least once a month according to estimates. The first treatment recommendation for patients with GERD is to make lifestyle changes (e.g., diet, scheduled eating times and sleeping positions). Patients are also instructed to take medications—proton pump inhibitors; unfortunately, patients frequently increase their dosage and, over time, become dependent on these medications to control their symptoms. In addition, a variety of other health complications are linked to long-term, maximum-dose dependency on these PPIs.

A minimally invasive endoscopic treatment, performed without the need for external incisions through the skin, the TIF 2.0 procedure offers patients who require an anatomical repair an effective treatment option to correct the underlying cause of GERD. Most patients stop using daily medications to control their symptoms and had their esophageal inflammation (esophagitis) eliminated up to five years after the TIF procedure, based on clinical studies.

There have been over 20,000 patients who have benefited from the TIF procedure worldwide since the EsophyX® device launched. In the past ten years, more than 60 centers have published over 80 peer-reviewed papers. These studies have consistently documented improved outcomes on more than 1,300 unique study patients. For more information, please visit www.GERDHelp.com.

About Reimbursement

Commercial and federal insurance providers, representing more than 100 million lives, have recognized the value of the TIF procedure through recently expanded contract and coverage reimbursement. EndoGastric Solutions has confirmed coverage for all Medicare enrollees through Medicare Administrative Contractors (MACs)—CGS, First Coast, NGS, Noridian, Novitas, Palmetto, WPS.

The Federal Register annually posts unadjusted average payments specific to the CPT® code for physicians and hospital Ambulatory Payment Codes (APC), allowing patients to receive access to treatment more easily for GERD. For the TIF procedure, physicians can reference CPT Code 43210 EGD esophagogastric fundoplasty and hospitals can reference APC 5362 Level 2 Laparoscopy Procedures. CPT is a registered trademark of the American Medical Association.

About EsophyX® technology

The EsophyX technology is used to reconstruct the gastroesophageal valve (GEV) and restore its function as a barrier, preventing stomach acids from refluxing back into the esophagus. The device is inserted through the patient’s mouth with direct visual guidance from an endoscope. The U.S. Food and Drug Administration cleared the original EsophyX device in 2007. EndoGastric Solutions® launched the third generation EsophyX device, the EsophyX Z model, in 2015. The evolving EsophyX technology now enables surgeons and gastroenterologists to use a wider selection of endoscopes to treat the underlying anatomical cause of GERD. These options include lower profile and larger, high-definition models.

Indications

The EsophyX device with SerosaFuse® fasteners and accessories are indicated for use in transoral tissue approximation, full thickness plication and ligation in the gastrointestinal tract. They are indicated for the treatment of symptomatic chronic GERD in patients who require and respond to pharmacological therapy. The device is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia ≤ 2cm in size in patients with symptomatic chronic GERD. Patients with hiatal hernias larger than 2cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2cm or less.

About EndoGastric Solutions®

Based in Redmond, WA, EndoGastric Solutions, Inc. (www.EndoGastricSolutions.com), is a medical device company developing and commercializing innovative, evidence-based, incisionless surgical technology for the treatment of GERD. EGS has combined the most advanced concepts in gastroenterology and surgery to develop the Transoral Incisionless Fundoplication (TIF®) 2.0 procedure—a minimally invasive solution that addresses a significant unmet clinical need. Join the conversation on Twitter: @GERDHelp Facebook: GERDHelp and Google+: GERDHelp,LinkedIn: EndoGastric Solutions.